Chapter 01: Drug Development and Ethical Considerations

MULTIPLE CHOICE

1. The nurse is preparing to administer a schedule II injectable drug and is drawing up half of

the contents of a Single-use vial. Which nursing action is correct?

a. Ask another nurse to observe and cosign wasting the remaining drug from the vial.

b. Keep the remaining amount in the patient’s drawer to give at the next dose.

c. Record the amount unused in the patient’s medication record.

d. Dispose of the vial with the remaining drug into a locked collection box.

ANS: A

Schedule II drugs are controlled substances, and all must be accounted for. When wasting a

portion of a drug, another nurse should observe and cosign that a drug was wasted.

DIF: COGNITIVE LEVEL: Applying (Application)

TOP: NURSING PROCESS: Nursing Intervention

MSC: NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies

2. A patient is prescribed a medication and asks the nurse if the drug is available in a generic

form. The nurse understands that a generic medication will have a name that

a. is a registered trademark.

b. is always capitalized.

c. describes the drugs chemical structure.

d. is non-proprietary.

ANS: D

The generic name is the official, non-proprietary name for a drug. The brand name is the

trademark name and is always capitalized. The chemical name describes the chemical structure

of the drug.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A

MSC: NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies

3. A patient receives a prescription on which the provider has noted that a generic 

medicationmay be given.The patient asks the nurse what this means. What will the nurse tell 

the patientabout generic drugs?

a. They contain the same inert ingredients as brand-name drugs.

b. They have chemical structures that are identical to proprietary drugs.

c. They tend to be less expensive than brand-name drugs.

d. They undergo extensive testing before they are marketed.

ANS: C

Generic drugs are approved by the FDA if they are proved to be bioequivalent to the brandname drug. They tend to be less expensive because manufacturers of these drugs do not have

to do the extensive testing required of brand-name drugs before marketing. They are not

identical to brand-name drugs and often have different inert ingredients.

DIF: COGNITIVE LEVEL: Applying (Application)

TOP: NURSING PROCESS: Nursing Intervention: Patient Teaching

MSC: NCLEX: Management of Client Care

4. The nurse reviews information about a drug and notes the initials USP after the drugs official

name. The nurse understands that this designation indicates the drug

a. is a controlled substance.

Test Bank - Pharmacology: A Patient-Centered Nursing Process Approach (9th Edition,

2017)

PHARMACOLOGY 9TH EDITION MCCUISTION TEST BANK

b. is approved by the U.S. Food and Drug Administration (FDA).

c. is available in generic form.

d. meets quality and safety standards.

ANS: D

The USP designation is given to drugs that have met high standards for therapeutic use, patient

safety, quality, purity, strength, packaging safety, and dosage form by the United States

Pharmacopoeia National Formulary. The FDA classifies controlled substances with Roman

numerals from I to V. The USP designation does not indicate FDA approval. The USP

designation does not indicate generic availability.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A

MSC: NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies

5. The nurse is preparing to give a medication to a child. The child’s parent asks whether the

drug is safe for children. How will the nurse respond to the parent?

a. Drugs are tested on adults and safe doses for children are based on weights compared to

adult weights.

b. Drugs are deemed safe for children over time when repeated use proves effectiveness and

safety.

c. Drugs are tested for both efficacy and safety in children in order to be marketed for pediatric

use.

d. Drugs are tested on children in post marketing studies and on a limited basis.

ANS: C

The Pediatric Research Equity Act requires drug manufacturers to test drugs on children.

DIF: COGNITIVE LEVEL: Applying (Application)

TOP: NURSING PROCESS: Nursing Intervention

MSC: NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies

6. Which law(s) govern all drug administration by nurses?

a. Drug Regulation and Reform Act

b. FDA Amendments Act

c. Nurse Practice Acts

d. The Controlled Substances Act

ANS: C

Each states Nurse Practice Act identifies how nurses administer medications. The other acts

govern how drugs are marketed and tested.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A

MSC: NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies

7. The nurse administers a drug and miscalculates the dose by placing the decimal place one

space to the right, resulting in a 10-fold overdose and the death of the patient. What offense

does this represent?

a. Malfeasance

b. Malpractice

c. Misfeasance

d. Nonfeasance

ANS: C

Misfeasance is negligence in giving either the wrong drug or the wrong dose, resulting in the

death of the patient.

Test Bank - Pharmacology: A Patient-Centered Nursing Process Approach (9th Edition,

2017)

PHARMACOLOGY 9TH EDITION MCCUISTION TEST BANK

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A

MSC: NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies

8. The nurse is busy and neglects to give a drug to a patient resulting in the patient’s death.

What offense does this represent?

a. Malfeasance

b. Malpractice

c. Misfeasance

d. Nonfeasance

ANS: D

Nonfeasance is omitting a drug dose, resulting in the patient’s death.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A

MSC: NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies

9. A patient is taking methadone as part of a heroin withdrawal program. The nurse understands

that, in this instance, methadone is classified as which drug schedule?

a. C-I

b. C-II

c. C-III

d. C-V

ANS: B

Methadone is a category II drug, with a high potential for drug abuse.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A

MSC: NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies

10. The nurse is preparing to administer a combination drug containing acetaminophen and

codeine. The nurse

knows that this drug is classified as which drug schedule?

a. C-II

b. C-III

c. C-IV

d. C-V

ANS: B

Codeine is normally a category II drug, except when it is part of a combination product such as

with acetaminophen, making it a category III drug.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A

MSC: NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies

11. The nurse is obtaining consent from a subject newly recruited for a clinical drug trial that will

last for 6 months. All subjects will be given gift certificates for participating. One subject says,

Well, I guess if the drug doesn't work, I'll just have to put up with the symptoms for 6 months.

What will the nurse tell the subject?

a. Participation for the duration of the study is required.

b. Participation may end at any time without penalty.

c. Withdrawal from the study may end at any time, but the gift certificate will not be given.

d. You can request placement in the treatment group.

Test Bank - Pharmacology: A Patient-Centered Nursing Process Approach (9th Edition,

2017)

PHARMACOLOGY 9TH EDITION MCCUISTION TEST BANK

ANS: B

All participants have the right to autonomy, which is the right to self-determination. Patients

have the right to refuse to participate or to withdraw from a study at any time without penalty.

Patients generally are not allowed to choose participation in either the treatment or the control

group.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: Nursing Intervention

MSC: NCLEX: Management of Client Care

12. The nurse is assisting with a clinical drug trial in which the side effects of two effective drugs

are being compared. A patient who would benefit from either drug has elected to withdraw from

the study, and the nurse assists with the paperwork to facilitate this. This is an example of

a. autonomy.

b. beneficence.

c. justice.

d. veracity.

ANS: A

All participants have the right to autonomy, which is the right to self-determination. Patients

have the right to refuse to participate or to withdraw from a study at any time without penalty

even if the health care provider disagrees with that choice.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A MSC: NCLEX: Management of Client Care

13. During a clinical drug trial for a new medication, researchers note a previously unknown

serious adverse effect occurring in more than 50% of subjects. The study is discontinued. Which

ethical principle is being exercised?

a. Beneficence

b. Justice

c. Respect for persons

d. Veracity

ANS: A

Beneficence is the duty to do well and to not harm others. Once a serious adverse effect is

noted in a majority of subjects, researchers have an ethical obligation to stop the study.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A MSC: NCLEX: Management of Client Care

14. In a 5-year experimental clinical trial to investigate a new cancer treatment, researchers in

the second year note overwhelming improvement in almost all of the subjects in the treatment

group. The lead researcher elects to continue the study. Which ethical principle is being

violated?

a. Beneficence

b. Justice

c. Respect for persons

d. Veracity

ANS: B

The principle of justice requires that all people be treated fairly, including equal access to health

care for all.

Once a benefit is demonstrated, it should be available to all participants.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A MSC: NCLEX: Management of Client Care

Test Bank - Pharmacology: A Patient-Centered Nursing Process Approach (9th Edition,

2017)

PHARMACOLOGY 9TH EDITION MCCUISTION TEST BANK

15. The nurse is enrolling subjects for a double-blind experimental study. One patient asks the

nurse to explain the role of the experimental group. The nurse will explain that subjects in the

experimental group in this type of study

a. are selected for participation in that group.

b. have unique baseline characteristics.

c. receive a placebo.

d. receive the treatment being evaluated.

ANS: D

In a double-blind experimental study, subjects in the experimental group receive the treatment

or drug under study. They are randomly assigned and not selected. They should have similar

baseline characteristics to those in the control group. They do not receive a placebo.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: Nursing Intervention: Patient Teaching

MSC: NCLEX: Management of Client Care

16. The nurse is obtaining signatures on consent forms for participation in a clinical drug trial.

One patient says, “I’m not sure I want to do this, but I need the cash”. The nurse will take which

action?

a. Ask the patient to clarify concerns.

b. Reinforce that cash is given to all subjects equally.

c. Report this statement to the party named on the consent.

d. Review the elements of the study and obtain consent.

ANS: C

If a nurse suspects that a patient is being coerced to participate in the study, the nurse should

report this to the party named on the informed consent. When a patient verbalizes participation

based on a financial reward, there is an element of coercion.

DIF: COGNITIVE LEVEL: Applying (Application)

TOP: NURSING PROCESS: Nursing Intervention

MSC: NCLEX: Management of Client Care

17. Which is characteristic of preclinical in vivo testing?

a. A comparison of experimental and control data in animals

b. A study conducted in a test tube in a laboratory

c. A study that determines the parameters of safe therapeutic doses

d. A study to assess the seriousness of the disease to be treated

ANS: A

Preclinical in vivo testing is performed in animals or other living organisms. In vitro studies occur

in test tubes.

Safe therapeutic dose studies are part of clinical research. Prior to clinical trials, an assessment

is made of the disease and its seriousness.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A MSC: NCLEX: Management of Client Care

18. Many drugs marketed in the 1980s may not be effective in a majority of the population. The

nurse understands that this is because these drugs

a. did not pass through the appropriate phases of clinical trials.

b. did not require human subject protections and are invalid.

Test Bank - Pharmacology: A Patient-Centered Nursing Process Approach (9th Edition,

2017)

PHARMACOLOGY 9TH EDITION MCCUISTION TEST BANK

c. were not tested on women, minorities, or children.

d. were tested on healthy subjects only.

ANS: C

Drug research was historically done only with white males, causing uncertainty as to the validity

of the research results.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A MSC: NCLEX: Management of Client Care

19. The nurse is assisting with data collection in a study of drug effects in healthy subjects. The

nurse assists with blood and urine collection to determine serum drug levels and the presence

of metabolites in the urine.

Which phase of a drug study does this represent?

a. Phase I

b. Phase II

c. Phase III

d. Phase IV

ANS: A

Phase I drug trials are performed to assess safety and to identify the pharmacokinetics, such as

metabolism and elimination, of drugs in healthy subjects.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A MSC: NCLEX: Management of Client Care

20. The nurse is enrolling subjects for a clinical drug trial in which subjects will be randomly

assigned to either a treatment or a placebo group. The pills in both groups will be in identical

packaging with identical appearance. This is an example of which type of study?

a. Crossover

b. Double-blind

c. Open-label

d. Single-blind

ANS: B

In a double-blind study, neither the subject nor the health care provider knows which group the

subjects are in. Since there is no difference in the appearance or packaging of the pills, the

health care providers will not be aware of which subjects receive the experimental drug and

which ones receive the placebo.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A MSC: NCLEX: Management of Client Care

21. The nurse is assisting with a clinical drug trial to test the safe dose of an analgesic

medication and learns that subjects have been told that the study is about measuring the

analgesic effects. Which ethical principle has been violated?

a. Beneficence

b. Justice

c. Respect for persons

d. Veracity

ANS: D

Veracity requires health care professionals to tell the truth.

DIF: COGNITIVE LEVEL: Understanding (Comprehension)

TOP: NURSING PROCESS: N/A MSC: NCLEX: Management of Client Care